Central line cap care kit and methods of using the same

ABSTRACT

The present invention relates to a method of replacing a central line cap to a catheter, and a kit for central line cap care and replacement.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a divisional of U.S. patent application Ser. No.15/975,127 filed May 9, 2018, which claims priority to and the benefitof U.S. Patent Application Ser. No. 62/503,503, filed May 9, 2017, andU.S. Patent Application Ser. No. 62/616,476, filed Jan. 12, 2018, thedisclosures of which are hereby incorporated by reference in theirentireties.

FIELD OF THE INVENTION

The present invention relates to a kit for changing the cap on the hubof a central line catheter, and method for using the kit in changing thecap on the hub of a central line catheter in inpatient, outpatient,and/or at home settings.

BACKGROUND OF THE INVENTION

Central line-associated bloodstream infections (CLABSIs) are an ongoingconcern with patients requiring a central line or central venouscatheter (CVC). A central line is a catheter (tube) that is often placedin a large vein in, for example, the neck, chest or groin of a patientto provide medications or fluids or to collect blood for medical tests.Central lines are frequently used in intensive care units, and on cancerpatients receiving chemotherapy both in and out patients. These centralline catheters can in instances remain in place for weeks or months. Asa result, central lines can be a potential source of serious infection.According to the Center for Disease Control and Prevention (CDC), about41,000 bloodstream infections affect hospital patients with centrallines each year, of which up to 1 in 4 will die as a result thereof.CLABSIs result in thousands of deaths each year and billions of dollarsin added costs to the U.S. healthcare system.

A central line-associated bloodstream infection (CLABSI) is a seriousinfection that occurs when germs, such as bacteria or viruses, enter thebloodstream through contamination of the central line. Healthcareproviders should follow a strict protocol when inserting the line tomake sure the line remains sterile and a CLABSI does not occur. Inaddition to inserting the central line properly, healthcare providersshould use stringent infection control practices each time the line ischecked or the dressing surrounding the catheter is changed. Althoughprogress has been made through the years to minimize the risk ofCLABSIs, and guidelines have been set forth by the CDC for theprevention of intravascular catheter-related infections (O'Grady et al.(2011) Guidelines for the Prevention of Intravascular Catheter-RelatedInfections, 2011<https://www.cdc.gov/hicpac/pdf/guidelines/bsi-guidelines-2011.pdf)there still exists a need to develop improved products and methods forfurther reducing the risk of developing CLABSIs, such as, for example,improved products and methods involved in changing a cap to a centralline, particularly in view of the increasing prevalence of antibioticresistant bacteria, such as, for example, methicillin-resistantStaphylococcus aureus (MRSA), vancomycin-resistant Enterococcus (VRE)and carbapenem-resistant Enterobacteriaceae (CRE).

SUMMARY OF THE INVENTION

Provided herein are methods for changing a central line cap, and centralline cap care kits. As such, according to an aspect of the invention,provided is a method of changing a central line cap of a catheter of apatient comprising: providing a mask and head cover for caregiver andpatient, hand sanitizer, a plurality of sterile gloves, a plurality ofsterile antiseptic swabs, sterile forceps, a sterile towel, a pluralityof sterile gauze swabs, at least one pre-filled sterile flushing syringecomprising a physiologically appropriate injection solution, such as anisotonic injection solution, and a sterile field, wherein the caregiverperforms the steps of: conducting hand hygiene; closing a clamp on thecatheter or ensuring the clamp on the catheter is closed; having thecaregiver and patient each don a head cover and a mask; conducting handhygiene comprising using hand sanitizer; donning a first pair of sterilegloves; evacuating air from the sterile flushing syringe, attaching anew catheter cap to the sterile flushing syringe and filling the newcatheter cap with the physiologically appropriate injection solution;setting the flushing syringe with the attached new catheter cap on thesterile field; wiping down/cleaning an old catheter cap and tubing ofthe central line leading into the old catheter cap with a sterileantiseptic swab; spreading the sterile towel, with the sterile forceps,under the cleaned old catheter cap and central line; removing the firstpair of sterile gloves; donning a second pair of sterile gloves;removing the old catheter cap from the hub of the central line catheterusing a plurality of sterile gauze swabs to assist with removing the oldcatheter cap; cleaning the central line catheter hub with a sterileantiseptic swab in order to clean the central line and allowing thecentral line to dry; attaching the new catheter cap to the end of thehub of the central line catheter; opening the clamp on the catheter;flushing the catheter, for example, according to the institution'sprotocol; closing the clamp on the catheter; and removing the flushingsyringe from the new catheter cap, wherein the plurality of sterileantiseptic swabs, the sterile forceps, the sterile towel, the pluralityof sterile gauze swabs, the pre-filled sterile flushing syringe orsyringes comprising a physiologically appropriate injection solution andthe sterile field are sterile components and/or provided in a sterilepackage or environment.

According to another aspect of the invention, provided is a cap care kitfor a central line cap of a catheter comprising: a plurality of masksand head covers; hand sanitizer; a plurality of sterile gloves; aplurality of sterile antiseptic swabs; a sterile towel; sterile forceps;a plurality of gauze swabs; a plurality of pre-filled sterile syringescomprising a physiologically appropriate injection solution; and asterile field.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 depicts an example of kit components for central line capcare/replacement according to some embodiments of the invention. Thisembodiment may form an individual kit, a layer of a multilayered kit orthe components of this kit may be combined with the kit componentsdepicted in FIG. 2 .

FIG. 2 depicts a further example of kit components for central line capcare/replacement according to some embodiments of the invention. Thisembodiment may form an individual kit, a layer of a multilayered kit orthe components of this kit may be combined with the kit componentsdepicted in FIG. 1 .

DETAILED DESCRIPTION

The invention will now be described more fully hereinafter. Theinvention, however, may be embodied in many different forms and shouldnot be construed as limited to the exemplary embodiments as set forthherein. Rather, these embodiments are provided so that the disclosureswill be thorough and complete, and will fully convey the scope of theinvention to one of ordinary skill in the art.

As used herein, “a,” “an” or “the” can mean one or more than one. Alsoas used herein, “and/or” refers to and encompasses any and all possiblecombinations of one or more of the associated listed items, as well asthe lack of combinations when interpreted in the alternative (“or”).

As used herein, “sterile” refers to free or essentially free ofmicroorganisms. In a sterile environment, the chances of contaminationby pathogenic organisms are reduced or eliminated.

As used herein, “essentially free” refers to 85%, 86%, 87%, 88%, 89%,90%, 91%, 92%, 93%, 94%, 95%, 96%, 97%, 98%, 99%, 99.9% or 100% free.

As used herein, “hand sanitizer” or “hand sanitizing composition” refersto a substance used for or capable of cleaning the hands (or a surfacein need thereof) so that they are free or essentially free ofmicroorganisms, and examples include, soap (and water), alcohol,benzalkonium chloride, triclosan, povidone, iodine and combinationsthereof.

As used herein, “pathogenic” or “microorganism” refer to bacteria,viruses, fungi and the like that can cause infection and/or disease.

As used herein, “towel” refers to a material such as a cloth or paperthat may have a plastic backing, of any dimension suitable for thedesired purpose that can be used as a surface or placed on an existingsurface.

As used herein, “disinfecting” refers to microstatic or microbicidalaction against a microorganism.

As used herein, “swab” refers to an absorbent piece of material that canbe used for cleaning as described herein.

As used herein, “sterile packaging” refers to a sterile package thathouses components and may provide a sterile or aseptic environment.These may be in the form of a “peel package” or “peel pack” ororganizing trays that may include associated coverings or containmentssuch as plastic, paper, metal or foam.

As used herein, “patient” refers to a subject. In particularembodiments, the subject is a human; however, a subject, and thus, apatient with respect to this invention can include an animal subject,particularly mammalian subjects such as canines, felines, bovines,caprines, equines, ovines, porcines, rodents (e.g. rats and mice),lagomorphs, primates (including non-human primates), etc., forveterinary medicine or pharmaceutical drug development purposes.

The subject or patient may be male, female or transgender and may be ofany race or ethnicity, including, but not limited to, Caucasian,African-American, African, Asian, Hispanic, Indian, etc. The subjectsmay be of any age, including newborn, neonate, infant, child,adolescent, adult, and geriatric. In some embodiments, the subject issuffering from an infectious disease, cancer, a critical illness or needintensive care.

As used herein, “kit” refers to an assembly of components packagedtogether with optional instructions regarding how to use the componentsof the kit. According to embodiments of the present invention, the kitsmay include all components of the elements described herein for caringfor a cap for a central line catheter of a patient, or a subset of theelements in any combination. That is, the kit may optionally includesome of the following, but not necessarily all of a head cover, mask,hand sanitizer, gloves, syringe(s) including pre-filled syringes, swab,gauze, alcohol swab, forceps, sterile towel, and disposable sterilesurface.

Embodiments of the present invention include methods for caring for acap for a central line catheter of a patient, and more particularly ahuman patient. In some embodiments, care for a cap for a central linecatheter includes replacing a cap for a central line catheter, forexample, a cap that is presently covering the lumen of the central line,with a new cap. The frequency for replacing a central line cap is notparticularly limited. For example, the central line cap may be changedonce every 7 days, or once every week. Nevertheless, the frequency ofreplacing the central line cap may be varied as would be appreciated byone of ordinary skill in the art, for example, every other day, threedays (72 hours), four days, five days, six days, seven days (1 week),eight days, nine days or 10 days. It would also be appreciated by one ofordinary skill in the art that the central line cap may also be replacedshould the cap become contaminated or soiled or suspected of beingcontaminated or soiled, or after a blood draw, or administration ofchemotherapy, or administration of a blood product, such as, wholeblood, plasma, or platelets, regardless of the previously selectedfrequency for replacing the central line cap.

The method of changing the central line cap may include, for example,several components that may be provided in, for example, a kit forreplacing a central line cap. In some embodiments, the kit may provide:at least one mask and at least one head cover for a caregiver and/or apatient; hand sanitizer; at least one pair of sterile gloves; at leastone sterile antiseptic swab; at least one set of sterile forceps; atleast one sterile towel, at least one sterile gauze swab; at least onepre-filled sterile flushing syringe including a physiological solutionsuch as an isotonic solution, for example, a 0.9% sodium chloride, ornormal saline, injection solution; and a sterile field. The site atwhich the method of the invention may take place is not particularlylimited. For example, the method may take place in an inpatient setting,for example, at a hospital in which the patient has been admitted, in anoutpatient setting, for example, at a clinic in which the patient doesnot stay overnight for the procedure, an urgent care setting or even atthe home/residence of the patient.

Prior to proceeding with steps for changing the central line cap, insome embodiments, the method includes the caregiver conducting handhygiene, which may include, for example washing of hands with soap andwater, and/or optionally using conventional lotion, gel or foam handsanitizer according to procedures that would be appreciated by one ofordinary skill in the art, for example, according to institutionalprotocols for conducting hand hygiene. In addition, prior to proceedingwith the method, the caregiver may close a clamp to the central line, orensure that the clamp to the central line is closed, in any manner orprocedure as would be appreciated by one of ordinary skill in the art.

In some embodiments, the method includes both the caregiver and thepatient donning or wearing both a mask, for example, but not limited to,an operating room (O/R) mask, and a head cover, for example, but notlimited to, O/R head covers, in order to prevent contamination of thecentral line, by for example, but not limited to, breathing on thecentral line. Should any additional individuals be present while thecentral line cap is being changed, these individuals may also don orwear a mask and/or a head cover during the procedure, preferably both.The caregiver, patient and/or additional individuals present may alsowear and change gloves during practice of the methods of the presentinvention.

In some embodiments, the method may include the caregiver using handsanitizer and waiting for hands to dry following the donning of the headcover and mask. This may be followed by the donning of a first pair ofsterile gloves prior to proceeding with changing the central line cap ofthe catheter.

The steps of changing the central line cap may include attaching a newcatheter cap onto a sterile flushing syringe. The nature of the cathetercap is not particularly limited, and the catheter cap used in theprocess may be of any variety available to one of ordinary skill in theart. The nature, for example, the size or volume, of the sterileflushing syringe is also not particularly limited. However, in someembodiments, the sterile flushing syringe may be a 10 ml syringe that ispre-filled with an isotonic solution, for example, a 0.9% saline (sodiumchloride), or normal saline, solution, as would be appreciated by one ofordinary skill in the art. In some embodiments, the isotonic solutionmay comprise heparin, for example, a heparin saline flushing solution.The sterile flushing syringe may then be purged of air by, for example,holding the sterile flushing syringe with the cap attached straight upand the plunger of the syringe pointing toward the floor, tapping thesyringe so that any air bubbles rise to the top of the syringe, andpushing the plunger up to force out any air in the syringe. The newcentral line cap may now be attached and the new central line cap maynow be filled with the flushing solution, such as 0.9% saline asdescribed above. In the alternative, the new central line cap may beattached to the sterile flushing syringe, and then both the syringepurged of air and the new central line cap filled with flushing solutionby inverting the syringe with attached new central line cap, tapping thesyringe to cause air bubbles to rise to the top of the syringe, andforcing out any air in the syringe and new central line cap. In someembodiments, the sterile flushing syringe may comprise a LUER-SLIP™connector, or a LUER-LOK™ threaded connector, to secure the new centralline cap thereto. The amount of flushing solution such as 0.9% saline inthe syringe after forcing air out may be, for example, at the 5 ml, 6ml, 7 ml, 8 ml, or 9 ml mark, or any volume within the range from aboutthe 5 ml mark to about the 9 ml mark. The new central line cap is nowprimed to replace the old central line cap, and may be set aside priorto removal of the old central line cap and cleaning the lumen, alsoknown as the hub, of the central line catheter.

In some embodiments, the primed new central line cap attached to thesterile flushing syringe may be set aside on a sterile field, which willbe detailed later. According to a conventional method for changing acentral line cap, neither sterile gloves, nor any gloves at all, arerequired, and the sterile flushing syringe with the new central line capattached thereto may be set on a non-sterile surface, such as a table,so long as the tip of new central line cap in not touched, which maylead to additional potential sources of contamination in the method ofchanging the central line cap.

In some embodiments, prior to removal of the old central line cap, theold central line cap and tubing from the central line of the catheterleading into the central line cap may now be wiped down and/or cleaned.This method may be performed by, for example, holding the central linecatheter in one hand, and cleaning the old central line cap and tubingleading into the cap with an antiseptic swab in the other hand.Following wiping down and cleaning, the antiseptic swab may bediscarded, and, in some embodiments, a sterile towel may be laid underthe central line of the catheter that has just been wiped and cleanedwith, for example, the assistance of a sterile set of forceps. Theforceps may be disposable, and can be discarded following setting of thesterile towel under the area of the central line of the catheter.

The nature of the antiseptic cleaning product such as a swab or wipe isnot particularly limited and may be a sterile cleaning product selectedfrom the group consisting of alcohol swabs and sterile sponges,including an antiseptic product, for example impregnated with anantiseptic product. In some embodiments, the cleaning product such as aswab, cloth, wipe, or sponge, may include any antiseptic that would beappreciated by one of ordinary skill in the art. For example, theantiseptic of the swab, cloth, sponge, wipe, etc. may includechlorhexidine, povidone, iodine, an iodophor, or alcohol. In someembodiments, the antiseptic cleaner is an alcohol swab including 70%isopropyl alcohol. In some embodiments, the antiseptic cleaner ischlorhexidine (such as SITE-SCRUB®).

Prior to removing the old central line cap and attaching the new centralline cap to the hub of the central line, in some embodiments, thecaregiver may discard the first pair of sterile gloves and don a secondpair of sterile gloves. In some embodiments, after removing the firstpair of sterile gloves and prior to the donning of the second pair ofgloves, hand hygiene and/or use of hand sanitizer may be conducted.

The old catheter cap may now be removed/unscrewed from the hub of thecentral line and discarded. In some embodiments, removal of the oldcentral line cap may be assisted by the use of one or more than onesterile gauze swabs. Following removal, the old catheter cap may bediscarded, and the lumen or hub of the central line is scrubbed orcleaned with a sterile antiseptic swab, for example, a sterile alcoholswab including 70% isopropyl alcohol or an antiseptic cleaner includingchlorhexidine, for at least 5 seconds according to procedures that wouldbe appreciated by one of ordinary skill in the art. In some embodiments,the lumen or hub may be scrubbed for at least 5 seconds to about 15seconds. Following scrubbing/cleaning, the lumen should not be permittedto touch anything, and the antiseptic swabs used in thescrubbing/cleaning of the lumen or hub of the central line may bediscarded.

The new catheter cap may now be attached to the lumen or hub of thecentral line, and flushed with the pre-filled sterile flushing syringefollowing opening of the clamp on the catheter. The flushing proceduremay be performed using any standard protocol as would be appreciated byone of ordinary skill in the art, for example, flushing the central lineaccording to institutional protocols, such as is set forth in, forexample, Brigham and Women's Hospital and the Dana-Farber CancerInstitute, “Changing Your Central Line Catheter Cap”(<http://www.dana-farber.org/uploadedFiles/Library/health-library/articles/changing-your-central-line-catheter-cap.pdf).The clamp on the catheter may now be closed, and the flushing syringeremoved from the new catheter cap. In some embodiments, an alcohol capor cover, for example a CUROS® (3M™) disinfecting port protector, may beattached to the new central line cap after the flushing syringe has beenremoved.

The procedure as described herein exemplifies the changing of a centralline cap for a single lumen central line. However, the procedure may berepeated if, for example, the central line includes a double lumen, suchas, for example, a Hickman central line, in which more than one centralline cap must be replaced. As such, in some embodiments, more than onepre-filled flushing syringe and more than one new central line cap maybe provided, and optionally, more than one cap or cover may be provided,if more than one central line cap is in need of replacement. Forexample, following replacement of a first central line cap, a second newcentral line cap may be primed with a second pre-filled flushingsyringe, and the steps for replacing a central line cap, such asdescribed herein, may be performed in order to replace a second centralline cap, such as with a double lumen Hickman central line catheter, orif a patient has more than one single lumen central line catheter.

In still other embodiments of the invention, provided is a kit forcentral line cap care, or for changing a central line cap of a catheter.The kit may include all of items or components required to carry out themethod of the invention as described herein. For example, the kit mayinclude: a plurality of masks and head covers; hand sanitizer; aplurality of sterile gloves; a plurality of sterile antiseptic swabs; asterile towel; sterile forceps; a plurality of sterile gauze swabs; atleast one pre-filled sterile flushing syringe comprising a saline (suchas 0.9% sodium chloride) injection solution; and a sterile field. A newcentral line cap or a plurality of new central line caps may be providedseparately or as part of the kit.

In some embodiments, the kit for central line cap care or changing acentral line catheter cap may provide various individual items orcomponents required to carry out the method of the invention asdescribed herein in separate packs or packages. For example, one pack orpackage of the kit may include: a plurality, or at least two, headcovers; a plurality, or at least two, masks (for both caregiver andpatient); hand sanitizer; and a plurality, or at least two pairs ofsterile gloves, and a second pack or package of the kit may include: aplurality of sterile antiseptic swabs; a sterile towel; sterile forceps,more particularly disposable sterile forceps; a plurality of sterilegauze swabs or pads; at least one, or a plurality, of pre-filled sterileflushing syringe; and a sterile field.

In some embodiments, the second package and the contents containedtherein, as provided, are sterile, i.e., the second pack or package is asterile pack or package. The nature of the sterile pack or package isnot particularly limited, and may be of any form that may be appreciatedby one of ordinary skill in the art. In some embodiments, the sterilepack or package may be a peel-pouch, a peel-pack, or peel-package. Insome embodiments, the individual contents of the second pack or package,for example, the sterile antiseptic swabs, the sterile towel, sterileforceps, sterile gauze swabs or pads; the pre-filled sterile flushingsyringe(s) and/or the sterile field, may be provided in sterilepeel-pouches, sterile peel-packs or sterile peel-packages within thesecond pack or package.

The second pack or package may include a sterile field. The nature ofthe sterile field is not particularly limited, so long as the pre-filledsterile flushing syringe(s) with a new central line cap attached theretomay be set thereon. In some embodiments, the sterile field may be awrapper for the contents of the second package. In some otherembodiments, the sterile field may be the container or a portion of thecontainer, in which the contents of the second pack or package areprovided. The container may include separators or dividers in which thecontents are disposed, or to provide an area upon which a new centralline cap or caps, or the pre-filled sterile flushing syringe(s) with anew central line cap attached thereto, may be set thereon when changinga central line catheter cap.

In some embodiments, the individual contents of the first pack orpackage, for example, the head covers, the masks, the hand sanitizer,and/or the sterile gloves, may be provided in sterile peel-pouches,sterile peel-packs or sterile peel-packages.

The manner in which the two packs or packages including the contents ofthe kit of the invention are disposed is not particularly limited. Insome embodiments, the first and second packs or packages of the kit ofthe present invention may be provided separately or combined. In otherembodiments, the first and second packs or packages of the kit of thepresent invention may be provided together as a single unit, in whichthe first pack or package can be provided as a first or upper “layer,”and the second pack or package, which in some embodiments, is sterile,can be provided as a second or lower layer of the kit. Exemplary layersof the first pack and the second pack of an embodiment of the kit aredepicted in FIGS. 1 and 2 . FIG. 1 shows the contents of the first orupper pack/layer of the kit, including head covers, masks, handsanitizer and gloves, whereas FIG. 2 shows the contents of the second orlower pack/layer of the kit, including the plurality of sterileantiseptic swabs, the sterile towel, sterile forceps, the plurality ofsterile gauze swabs or pads, the at least one or a plurality ofpre-filled sterile flushing syringes. In some embodiments, the containerand the contents of the second pack or package are sterile. The secondpack or package, for example, the container, such as is depicted in FIG.2 , may serve as, in some embodiments, the sterile field on which a newcentral line cap that has been attached to a pre-filled sterile flushingsyringe may be set prior to attaching the new central line cap to thelumen/hub of the central line. In other embodiments, the sterile secondpack or package may include a sterile wrapper for the contents therein,which may serve as the sterile field.

The sterile field is provided so as to further reduce the risk ofcontamination, which may lead to a CLABSI, during a central line capchange procedure by providing an aseptic area on which components usedin the central line cap change procedure may be set. The sterile fieldmay also facilitate use of the kit for changing a central line cap inenvironments other than in a hospital, i.e., inpatient, or a clinic,i.e., outpatient setting. For example, the kit may facilitate changing acentral line cap at the home/residence of a patient (i.e., where thepatient is staying outside of a hospital or clinical setting), whilereducing the risk of contamination and infection in such a setting.

In yet other embodiments, the kit, and the contents of the kit, can belatex-free so as to avoid potential latex sensitivity or allergies ofeither the patient or the caregiver. The kit may also optionallyinclude, for example, alcohol covers for the central line caps, whichmay be provided separately from the first and second pack or packages ofthe kit.

According to further embodiments of the invention, the method forchanging a central line cap of a catheter of a patient, as set forthherein, may be performed using a kit, for example, a cap care kit, suchas is set forth herein. In some embodiments, the method of for changinga central line cap for a catheter may include providing a plurality ofmasks and head covers for caregiver and patient, hand sanitizer, aplurality of sterile gloves, a plurality of sterile alcohol swabs,sterile forceps, a sterile towel, a plurality of sterile gauze swabs, atleast one pre-filled sterile flushing syringe comprising a saline (suchas 0.9% sodium chloride) injection solution and a sterile field in akit, such as is set forth herein. The provided kit and componentstherein may be accessed or opened, for example, after the caregiver hasconducted hand hygiene and has closed or ensured that the clamp on thecatheter or ensuring the clamp on the catheter is closed.

EXAMPLE Changing of Central Line Cap

The following example has been included to provide guidance to one ofordinary skill in the art for practicing representative embodiments ofthe presently disclosed subject matter. In light of the presentdisclosure and the general level of skill in the art, those of skill canappreciate that the following example is intended to be exemplary onlyand that numerous changes, modifications, and alterations can beemployed without departing from the scope of the presently disclosedsubject matter.

At least some, if not all, of the following components are included asan assembly of components, which may be included as part of a sterileenvironment:

-   -   Head cover    -   Mask    -   Hand sanitizer    -   Plurality of sterile gloves    -   Sterile forceps,    -   Sterile towel,    -   Sterile gauze    -   Sterile pre-filled flushing syringe—comprising of sodium        chloride (e.g., 0.9% sodium chloride injection 10 mls) (at least        one)    -   Sterile field    -   Plurality of sterile cleaning products (e.g., alcohol swabs,        sterile sponges, which can be impregnated with an antiseptic        product such as chlorhexidine (CHG) and povidone—iodine

At least some, if not all, of the following steps may be carried out inthe exemplary procedure:

-   -   (a) Conducting hand hygiene    -   (b) Explain the procedure to the patient and or family member    -   (c) Closing the clamp on the catheter or ensure that it is        closed    -   (d) Open the kit    -   (e) Remove head cover, mask, hand sanitizer and 1^(st) pair of        sterile gloves from a 1^(st) layer of kit (FIG. 1 )    -   (f) Have care giver (and patient each) don head cover and mask    -   (g) Open the 2^(nd) layer of the kit (FIG. 2 )    -   (h) Peel open the sterile cap into the kit    -   (i) Care giver use hand sanitizer—allow to dry    -   (j) Don the 1^(st) pair of sterile gloves    -   (k) Evacuate air from flushing syringe    -   (l) Attach the new sterile cap to the flushing syringe, filling        it with a physiological solution such as sodium chloride    -   (m) Set the flushing syringe with the attached new catheter cap        on the sterile field    -   (n) Wipe down and clean the used catheter cap and section of        tubing leading to the cap with antiseptic swab. Allow to dry    -   (o) Use sterile forceps to spread sterile towel under the        cleaned used catheter cap and central line    -   (p) Remove 1^(st) pair of sterile gloves    -   (q) Don 2^(nd) pair of sterile gloves    -   (r) Remove the used cap from the central line with the        assistance of sterile gauze if necessary and discard same    -   (s) Clean the hub of catheter with antiseptic swab (as per        institution's protocol)—using friction and twisting motion        (allow to dry)    -   (t) Attach the new cap with the flush syringe to the hub of the        catheter    -   (u) Open the clamp on the catheter    -   (v) Verify blood return    -   (w) Flush catheter (as per institution's protocol)    -   (x) Close clamp on catheter    -   (y) Remove flushing syringe from the new catheter cap    -   (z) Repeat above for all other lumens. Using new wipes, flushing        syringes, towel and gloves as needed

Optional post-procedure protocol includes the following:

-   -   Discard supplies    -   Remove gloves and hat    -   Wash hands with soap and water

In general, the invention provides methods and kits that allow thesterile changing of a cap of a central line of a catheter. Components asneeded to achieve the same are provided in sterile packaging in order tomaintain a sterile environment. Thus, the components can be provided forconvenience within a sterile package altogether or in multiple sterilepackages to comprise a kit. Moreover, those components that can bepre-purchased as sterile can be provided separately and combined poststerilization with components that require sterilization after purchasein order to provide sterile components and a sterile environment forchanging, replacing or establishing the cap of a central line of acatheter.

While the present invention has been shown and described with referenceto some embodiments thereof using specific terms, the embodiments andterms have merely been used to explain the present invention and shouldnot be construed as limiting the scope of the invention as defined bythe claims. Therefore, the scope of the invention is not defined by thedetailed description, but by the appended claims, and all differenceswithin the scope will construed as being included in the invention.

That which is claimed is:
 1. A cap care kit for a central line cap of acatheter consisting of: a plurality of masks and head covers; handsanitizer; a plurality of sterile gloves; sterile forceps; a steriletowel; a plurality of gauze swabs or pads; at least one pre-filledsterile flushing syringe comprising a physiological injection solution;a sterile field; a plurality of sterile cleaning products; and whereinthe contents of the cap care kit are housed in a packaged container. 2.The cap care kit of claim 1, wherein the plurality of masks and headcovers, hand sanitizer, and the plurality of sterile gloves are providedin a first package, and, the stele towel, sterile forceps, and the atleast one pre-filled sterile flushing syringe are provided in a secondpackage.
 3. The cap care kit of claim 2, wherein the first and secondpackages of the kit comprise a single unit in which the first packagecomprises an upper layer and the second package comprises a lower layerof the kit.
 4. The cap care kit of claim 3, wherein the second packageis sterile.
 5. The cap care kit of claim 1, wherein the cap care kit islatex-free.
 6. The cap care kit of claim 1, wherein the cap care kitcomprises a plurality of sterile pre-filled flushing syringes.
 7. Thecap care kit of claim 1, wherein the contents of the cap care kit aresterile.
 8. A cap care kit for a central line cap of a catheterconsisting essentially of: a plurality of masks and head covers; handsanitizer; a plurality of sterile gloves; sterile forceps; a steriletowel; a plurality of gauze swabs or pads; at least one new central linecatheter cap; at least one pre-filled sterile flushing syringecomprising a physiological injection solution; a plurality of sterilecleaning products; and wherein the contents of the cap care kit arehoused in a packaged container wherein the container or a portionthereof is a sterile field.
 9. The cap care kit of claim 8, wherein thecontainer comprises a divider defining air area wherein the contents ofthe cap care kit are disposed after use.
 10. The cap care kit of claim8, wherein the container comprises a divider defining and area wherein anew central line cap and/or a sterile flushing syringe with a newcentral line cap attached thereto may be set thereon when changing acentral line catheter cap that is in use.
 11. The cap care kit of claim8, wherein the plurality of sterile cleaning products is selected fromthe group consisting of alcohol swabs and sterile sponges comprising anantiseptic product.
 12. The cap care kit of claim 8, wherein theplurality of masks and head covers, hand sanitizer, and the plurality ofsterile gloves are provided in a first package, and, the plurality ofsterile cleaning products, and the at least one pre-filled sterileflushing syringe are provided in a second package.
 13. The cap care kitof claim 12, wherein the first and second packages of the kit comprise asingle unit in which the first package comprises an upper layer and thesecond package comprises a lower layer of the kit.
 14. The cap care kitof claim 8, wherein the contents of the cap care kit are sterile.
 15. Acap care kit for a central line cap of a catheter consisting essentiallyof: a plurality of masks and head covers; hand sanitizer; a plurality ofsterile gloves; sterile forceps; a sterile towel; a plurality of gauzeswabs or pads; at least one pre-filled sterile flushing syringecomprising a physiological injection solution; a sterile field; aplurality of sterile cleaning products selected from the groupconsisting of alcohol swabs and sterile sponges comprising an antisepticproduct; and wherein the contents of the cap care kit are housed in apackaged container.